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FDA To Review Anti-Smoking Drug, Chantix, For Risk Of Psychiatric, Behavioral Side Effects

The Food and Drug Administration plans to review the anti-smoking drug, Chantix, for possible psychiatric and behavioral risks after numerous reports of suicidal thoughts and actions from its users. Photo courtesy of Shutterstock

The Food and Drug Administration (FDA) plans to review the popular smoking cessation medication, Chantix, in order to determine whether its benefits of helping a smoker quit are greater than its psychiatric and behavioral risks. Since 2009, the medication has been sporting a “black box” label, which is the government’s strongest safety warning. The FDA will soon meet with a panel of psychiatric drug experts to further discuss Chantix’s side effects.

Chantix has been linked with psychiatric side effects since its release in 2006. According to Time, there have been dozens of suicides and hundreds of reports of suicidal behavior among the drug’s users. In 2009 the FDA required that its manufacturer, Pfizer, conduct additional studies to better understand the drug’s dangerous side effects. Victoria Davis, spokeswoman for Pfizer, announced that the company has recently submitted new data to the FDA comparing the drug’s psychiatric safety to placebo and other anti-smoking techniques. “ Pfizer has proposed an update to the Chantix labeling based on these new data, which we believe, would better reflect the product’s safety profile as it pertains to neuropsychiatric symptoms, Davis wrote in a statement, as reported by ABC News. A public meeting is planned in October to discuss the new information.

Chantix is a twice-a-day pill marketed to help the users quit smoking. The drug works by blocking the pleasurable effects of smoking in the brain, thus decreasing your desire to smoke. It is meant to be used together with behavior modification and counseling. Chantix’s most common side effects are abnormal dreams, trouble sleeping, and unusual tiredness and weakness. According to the drug's website other possible side effects include “hostility, agitation, depressed mood, and suicidal thoughts or actions.” Time reported that sales of the drug and shares of Pfizer have continued to fall since the drug first hit the market eight years ago.

Chantix has been at the center of a recent murder case involving California native Tim Danielson, who is standing trial for murdering his wife. It is understood that Danielson was suffering from depression at the time the crime was committed. Danielson’s defense attorney linked his depression to the Chantix he had taken only a few weeks prior to the crime. The judge agreed to allow the “Chantix defense” to be used in court. Yet, Pfizer released a statement defending the smoking cessation medication. “Chantix has been studied extensively and there is no reliable scientific evidence that the medicine causes serious neuropsychiatric events like the violence in this case,” a Pfizer spokesperson told ABC 10 News.